engineer.waltham , massachusettsposted todayjob detailssummary$52.60 - $73.64 per hourcontractbachelor degreecategory computer and mathematical occupationsreference1069219job detailsjob summary:A Engineer is needed for a research-driven biopharmaceutical company in the Waltham, MA area. The role involves leading manufacturing process improvement projects, conducting data analysis, troubleshooting, and ensuring compliance in pharmaceutical production, while providing technical support, managing small projects, and maintaining documentation for regulatory standards.location: Waltham, Massachusettsjob type: Contractsalary: $52.60 - 73.64 per hourwork hours: 8am to 5pmeducation: Bachelorsresponsibilities:Lead projects in manufacturing processes to achieve:Increased process yieldQuality improvementsReduced cycle time/throughputCost reduction initiativesGather and analyze process data using statistical process control methods.Develop action plans to:Increase process robustnessPrevent product lossControl quality impactParticipate in process performance monitoring activities such as "Track & Trend."Provide technical support for resolving shop floor issues and execute assigned tasks as required.Lead investigations using a structured problem-solving approach, ing scientific principles to:Identify root causesDevelop recommendations for product and process improvementGenerate technical justifications to support/document:Process deviations and investigationsImpact assessments on product quality, yield, and registrationWork with cross-functional teams on implementing site projects/initiatives, including:Continuous improvement effortsCost reduction measuresCapacity increasesManage small team projects or short-duration projects within larger initiatives, including:Project coordinationMonitoring and reportingMeeting managementTeam communicationLead the implementation of process validation for:Operational changesNew raw materialsNew process/technology introductionGenerate technical justifications to determine the impact of changes and create protocols, reports, and manufacturing documents.Support experimental, demonstration, and validation runs.Maintain up-to-date product process documentation, ensuring compliance with applicable procedures and regulations.Write justification memos and scientific reports related to quality controls and manufacturing documents.Provide scientific and technical support during regulatory audits and inspections.Demonstrate accountability and responsibility for EHS (Environmental, Health, and Safety) performance and compliance through active participation.Qualifications:BS or MS in Chemistry or Engineering (Chemical, Mechanical, Bio-chemical)5-7 years of technical experience in Process/Manufacturing/Project Engineering or a similar rolestrong technical knowledge of pharmaceutical solid dosage form processingEffective verbal and written communication skills in both English and SpanishScope of Work:Provide technical support in resolving shop floor situations and executing assigned tasks.Analyze process data using statistical process control methods.Develop action plans for process robustness, loss prevention, and quality control.Lead investigations to identify root causes and make recommendations.Document process changes with technical justifications.Support the execution of experimental, engineering, or process validation runs.Maintain compliance of process documentation, including manufacturing directions, batch records, and SOPs.Generate and review reports for regulatory agencies, such as Annual Product Reviews.Capabilities:In-depth knowledge of pharmaceutical manufacturing processesSkills in structured problem solving, continuous improvement, and project coordinationProficiency in technical writingqualifications:Experience level: ExperiencedEducation: Bachelorsskills:Project ManagementQuality ControlData AnalysisPharmaceuticalEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).This posting is open for thirty (30) days.